Serplulimab Combined With Anti-VEGF Antibody in Advanced Lung Adenocarcinoma

NCT ID: NCT05675033

Last Updated: 2023-01-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-10
• Study Completion Date: 2024-01-10

Brief Summary

In order to further evaluate the efficacy of immunotherapy combined with antivascular therapy in the real world, we used Serpluimab combined with Bevacizumab and platinum-based chemotherapy in previously untreated EGFR/ALK-negative advanced non-squamous NSCLC patients, to evaluate the efficacy and safety of this regimen.

Conditions

Lung Adenocarcinoma; Stage IV Non-small Cell Lung Cancer; PD-1 Inhibitor; VEGF

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

study arm

This is a single arm study.

Group Type: OTHER

Serplulimab and Bevacizumab injection

Intervention Type: DRUG

Serplulimab, 4.5mg/kg, intravenous injection, D1,Q21, until the disease progressed or showed intolerable side effects.

Bevacizumab injection, 7.5mg/kg, intravenous injection, D1, Q21, until the disease progressed or showed intolerable side effects.

Platinum-based chemotherapy: pemetrexed combined with carboplatin, D1-2, Q21, a total of 4 cycles.

Interventions

Serplulimab and Bevacizumab injection

Serplulimab, 4.5mg/kg, intravenous injection, D1,Q21, until the disease progressed or showed intolerable side effects.

Bevacizumab injection, 7.5mg/kg, intravenous injection, D1, Q21, until the disease progressed or showed intolerable side effects.

Platinum-based chemotherapy: pemetrexed combined with carboplatin, D1-2, Q21, a total of 4 cycles.

Intervention Type: DRUG

Other Intervention Names

platinum-based chemotherapy

Eligibility Criteria

Inclusion Criteria

• Fully understood this study and voluntarily signed the informed consent form (ICF);

-≥ 18 years and ≤ 75 years old;

• ECOG score 0-1;
• Non-squamous NSCLC;
• stage IV;
• EGFR and ALK negative;
• Treatment-naive;
• According to RECIST1.1 criteria, there are measurable or evaluable lesions.

Exclusion Criteria

• Tumor histology or cytology confirmed that it was associated with squamous cell carcinoma or small cell lung cancer;
• Patients with severe organ dysfunction were indicated by examination, Exclude subjects with any active, known or suspected autoimmune diseases;
• The estimated survival time is less than 3 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Mei Fang Li, MD

Role: CONTACT

362952772@qq.com

+8615985795022

Other Identifiers

SCOG004

Identifier Type: -

Identifier Source: org_study_id